FDA News

FDA approves brain stimulation device to ease Parkinson’s, essential tremor symptoms

The FDA today granted approval to the Brio neurostimulation system, which helps to reduce symptoms of Parkinson’s disease and essential tremor in patients for whom medication alone does not offer sufficient relief, according to a press release.

The Brio implant system (St. Jude Medical) operates off of a battery-powered, rechargeable electric pulse generator, which is inserted under the skin of the upper chest. Electrodes are placed within the brain at various locations, dependent upon the patient’s disorder, and attach to the generator through a series of wire leads. A low, continuous electrical pulse, which can be adjusted by health care providers, is then delivered to specific areas within the brain.

The FDA’s approval decision was based upon two clinical studies that evaluated the safety and efficacy of the system. According to study results, the Brio neurostimulation system significantly improved symptoms for patients with both Parkinson’s and essential tremor.

Intracranial bleeding, infection and device dislocation were reported as serious adverse events.

In 1997, the FDA approved Medtronic’s Activa deep brain stimulation therapy system for tremor associated with Parkinson’s and essential tremor, making the Brio neurostimulation system the second approved device for such symptoms.

“There are no cures for Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients. This new device adds to the array of treatment options to help people living with Parkinson’s and essential tremor enjoy better, more productive lives,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a press release.

The FDA today granted approval to the Brio neurostimulation system, which helps to reduce symptoms of Parkinson’s disease and essential tremor in patients for whom medication alone does not offer sufficient relief, according to a press release.

The Brio implant system (St. Jude Medical) operates off of a battery-powered, rechargeable electric pulse generator, which is inserted under the skin of the upper chest. Electrodes are placed within the brain at various locations, dependent upon the patient’s disorder, and attach to the generator through a series of wire leads. A low, continuous electrical pulse, which can be adjusted by health care providers, is then delivered to specific areas within the brain.

The FDA’s approval decision was based upon two clinical studies that evaluated the safety and efficacy of the system. According to study results, the Brio neurostimulation system significantly improved symptoms for patients with both Parkinson’s and essential tremor.

Intracranial bleeding, infection and device dislocation were reported as serious adverse events.

In 1997, the FDA approved Medtronic’s Activa deep brain stimulation therapy system for tremor associated with Parkinson’s and essential tremor, making the Brio neurostimulation system the second approved device for such symptoms.

“There are no cures for Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients. This new device adds to the array of treatment options to help people living with Parkinson’s and essential tremor enjoy better, more productive lives,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a press release.